Available Positions

Senior Clinical Research Associate at Pharmaceutical Company in Denver, Colorado, United States —

  • Pharmaceutical
  • Pharmaceutical Company
  • Denver, Colorado, United States
  • 8/10/19

Job ID: 335607

Job Description

Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (60% travel with 75% at peak times) to ensure the conduct of high quality clinical trials according to ICH-GCP Guidelines and according to SOPs.

  • Identify and contribute to a database of potential investigators for participation in clinical trials
  • Obtain, review for quality and completeness, and process regulatory, ethics and essential documents from investigator sites
  • Create and maintain appropriate trial-related documentation (including but not limited to the ITF, eTMF, correspondence, visits reports and follow-up letters)
  • Ensure that the investigator and site staff are adequately trained on protocol requirements, the investigational product, regulatory and ethical obligations, and A/E and SAE reporting
  • Ensure Serious Adverse Events (SAEs) are reported by the site according to the protocol; ensure full SAE reconciliation has been completed at the site level
  • Manage and report on the progress of the trial at assigned sites
  • Review and source document verify CRFs and verify other clinical data for completeness and accuracy; generate queries
  • Resolve queries in the eCRF data with study site personnel
  • Demonstrate technical competence and assist with user acceptance and implementation of electronic data capture (EDC) at sites
  • Review tables and listings generated from study data
  • Consult regularly with the investigator at the site concerning recruitment, retention strategies and other matters relating to the trial

Qualifications

  • Bachelor’s Degree in science or equivalent
  • 2 years’ work experience as a Clinical Research Associate
  • Thorough knowledge of ICH-GCP
  • Excellent written and verbal communications skills
  • Ability and willingness to travel up to 60% with 75% at peak times

Apply

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